switching to abilify trial (swat)

Conditions: Schizophrenia

Summary: to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration

this trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole administration to schizophrenic outpatients who maintain stable (no change with dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued previous antipsychotic drugs. aripiprazole (10\~30 mg/day) will be orally administered for 12 weeks followed by an extension phase for a maximum of an additional 14 weeks (total of 26 weeks).

Eligibility criteria:
inclusion criteria: * signed written informed consent * men and women, ages 18 to 65. women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. * patients who have not been hospitalized during last three months * patients who have kept clinically stable dosage during last one month * patients with a diagnosis of schizophrenia and schizoaffective disorder as defined by dsm-iv criteria * patients whose symptoms are not optimally controlled or whose antipsychotic medication is not well-tolerated, which in the clinical judgment of the treating psychiatrist require a change of treatment. * patients who have received antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine. exclusion criteria: * patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period * women who are pregnant or breastfeeding * patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide * patients with a diagnosis of bipolar disorder, depression with psychotic symptoms, or organic brain syndromes * patients who have met dsm-iv criteria for any significant psychoactive substance use disorder within the 3 months prior to screening * patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments * treatment with a long-acting antipsychotic (i.e., haloperidol decanoate or fluphenazine decanoate) in which the last dose was within 3 weeks of randomization. * patients with a history of neuroleptic malignant syndrome * patients with epilepsy, a history of seizures (except for a single childhood febrile seizure), or a history of an abnormal eeg, severe head trauma, or stroke or who have a history or evidence of other medical conditions (e.g., congestive heart failure) that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial * patients who would be likely to require prohibited concomitant therapy during the trial * patients who have previously enrolled in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month * prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Keywords: schizophrenia aripiprazole